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Update on KaloBios' KB004

KaloBios Pharmaceuticals, Inc. (KBIO) received a Notice of Allowance for a composition of matter patent covering certain antibodies targeting EphA3, which includes its oncology candidate KB004. The Notice of Allowance received from the U.S. Patent and Trademark Office validates the uniqueness of KB004 and the company’s Humaneered technology incorporated into it.

KaloBios is currently conducting a phase I study on its anti-EphA3 mAb, KB004, for the treatment of hematologic malignancies. KaloBios plans to start the phase II study evaluating the efficacy of KB004 in the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) by year end. Initial results from these studies are expected in the second quarter of 2015.

We are encouraged by KaloBios’ pipeline progress. Besides KB004, the company also has another interesting candidate in its pipeline - KB001-A, a second generation, anti-TTSS antibody. The candidate is currently in a phase II study for the treatment of chronic pseudomonas aeruginosa (Pa) infections in cystic fibrosis (CF) patients.

Enrollment is expected to complete in mid-2014 with top-line results due in the fourth quarter of 2014. KaloBios enjoys orphan drug status for KB001-A in the EU and U.S. The Food and Drug Administration (FDA) granted Fast Track Designation to KB001-A, for the treatment of Pa in the intensive care setting.

Meanwhile, KaloBios has completed enrollment of 160 patients in a phase II study on another candidate, KB003. KB003 is being studied for the treatment of severe asthma. KaloBios anticipates top-line results in the first quarter of 2014.

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